Drug product
Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
D-1423-2015
Product summary
- Event
- Event 71836
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5472 bottles
- Official record key
drug-enforcement:D-1423-2015
Official wording
Reason: Chemical Contamination; benzophenone leached from the product label varnish
Code information: lot #s 6671801, exp 12/16 and 6706401, exp 7/17
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination